Impact of the Therapeutic Alliance on Reduction of Disparities in Latino End-of-Life Cancer Care

Cancer Clinical Trial

Official title:

Impact of the Therapeutic Alliance on Reduction of Disparities in Latino End-of-Life Cancer Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04342611
• Other study ID #: 22466
• Secondary ID: 5K08CA245193-04
• Status: Recruiting
• Start date: May 19, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: Ana I. Tergas, MD
• Phone: 626-359-8111
• Email: atergas[@]coh.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to examine perceptions, barriers, and facilitators of a therapeutic alliance (TA) between Latino/a advanced cancer patients and their oncologists. We aim to qualitatively explore patient and oncologist perceptions of TA, barriers and facilitators of TA, and the perceived influence of Latino/a ethnicity on TA via in-depth interviews with oncologists (N=4) and focus groups with patients (N=10 patients). We hypothesize that we will be able to better understand the TA between Latino/a advanced cancer patients and their oncologists through the conduct of these focus groups and structured interviews .

Description:

Patients. We will conduct focus groups with patients (N=10) that will be recruited from City of Hope. Focus group participants will be recruited from the patients of participating oncologists, based on the eligibility criteria as above. Research staff will screen clinic rosters for eligible patients. Research staff will contact eligible patients, inform them of their potential eligibility for the study, and provide information about the study as detailed in the information sheet. The research staff invite the patient to participate in a focus group with other patients and obtain permission to record the focus group if the patient agrees to participate. The focus groups will explore patient perceptions of TA, barriers and facilitators of TA, and the perceived influence of Latino/a ethnicity on TA. Participants will be asked to provide demographic information.

Providers (oncologists). We will conduct in-depth interviews with oncologists (N=4) who work at City of Hope. Oncologists will be identified by convenience and purposive sampling. Oncologists will be contacted via email and invited to participate in a structured interview to explore oncologist perceptions of TA, barriers and facilitators of TA, and the perceived influence of Latino/a ethnicity on TA. Oncologists will also be provided with an information sheet and be asked permission to record the interview. Individual interviews will last around 30 to 45 minutes.

We will conduct in-depth interviews and focus groups with oncologists, patients to gain a more nuanced understanding of the TA and its relationship to EoL care for Latino/a advanced cancer patients. We chose focus group methods for patients to use interactions among participants that would capture the diversity of patient care-seeking experiences in a supportive environment.

The focus groups and structured interviews will be conducted via the Zoom platform. The audio from the focus group will be securely recorded and transcribed through the Zoom platform. Automated transcriptions will be edited for accuracy by members of the research team.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion criteria:

1. identifying as ethnically Latino/a;

2. locally advanced or metastatic cancer (gynecologic, lung, gastrointestinal, colorectal) and have experienced disease progression on at least first-line chemotherapy and

3. ability to provide informed consent.

Patient exclusion criteria include:

1. not fluent in English or Spanish;

2. severely cognitively impaired [44];

3. too ill or weak to participate in a focus group ;

4. age under 21; and

5. patients deemed inappropriate for the study by their treating oncologist.

Related Conditions & MeSH terms

• Cancer
• Death

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barriers and facilitators of the therapeutic alliance	This qualitative study seeks to primarily investigate the barriers and facilitators to developing a therapeutic alliance between patients and their oncologists. As a qualitative study, there will be no objective measurements or assessments. Participants will be asked to verbally describe barriers and facilitators of developing a TA with their oncologist.	Baseline
Secondary	Perceived influence of Latino/a ethnicity on the therapeutic alliance	Secondarily, this qualitative study seeks to understand the perceived influence of Latino/a ethnicity of the development of a therapeutic alliance between patients and their oncologist. As a qualitative study, there will be no objective measurements or assessments. Participants will be asked to verbally describe the perceived influence of Latino/a ethnicity on the development of a therapeutic alliance with their oncologist.	Baseline